Paget Disease of Bone
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Sign up freeTop drugs studied for this disease
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FDA approval · 2011-04-06FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for ALENDRONATE SODIUM from Aurobindo Pharma Limited, indicating approval of a supplemental submissi…
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FDA approval · 2011-04-01FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for alendronate sodium filed by Amneal Pharmaceuticals of New York LLC. This action updates the regu…
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FDA approval · 2011-02-15FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Alendronate sodium filed by Aurobindo Pharma Limited.
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FDA label_change · 2011-01-25FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for Actonel (risendronate sodium) filed by Allergan, Inc., to update the labeling related to its app…
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FDA approval · 2011-01-25FDA Approved: RECLAST — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for RECLAST (zoledronic acid) filed by Sandoz Inc.
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FDA approval · 2010-08-24FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for alendronate sodium from Aurobindo Pharma Limited, enabling the marketing of a generic produc…
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CLINICAL_TRIALS trial_result · 2010-07-13Clinical Trial Update: Genetic Study of Families Affected by Paget's Disease of Bone
This clinical trial update reports the completion of a genetic study examining families affected by Paget's Disease of Bone, aiming to under…
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CLINICAL_TRIALS trial_result · 2010-06-14Clinical Trial Update: Bioequivalence Study of Alendronate Sodium Tablets 70 mg of Dr. Reddy's Under Fasting Conditions [Phase 1]
This entry reports the completion of a Phase 1 bioequivalence study of Dr. Reddy's Alendronate Sodium 70 mg tablets under fasting conditions…
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FDA approval · 2010-04-22FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for ALENDRONATE SODIUM submitted by Amneal Pharmaceuticals of New York LLC.
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FDA label_change · 2009-12-31FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)
FDA approved Allergan's supplemental NDA for Actonel (risendronate sodium) to update the labeling, potentially adding or revising indication…
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FDA label_change · 2009-10-30FDA Approved: MIACALCIN — Supplemental Application (Mylan Institutional LLC)
FDA's page describes a supplemental application for Miacalcin (calcitonin salmon) submitted by Mylan Institutional LLC. The document signals…
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FDA approval · 2009-10-20FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for ALENDRONATE SODIUM from Amneal Pharmaceuticals of New York LLC, authorizing an additional regula…
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FDA approval · 2009-09-24FDA Approved: ALENDRONATE — Original Application (Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.)
FDA approved Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.'s generic alendronate (alendronate sodium tablets) via an Original Applicat…
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FDA approval · 2009-07-23FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for Actonel (risendronate sodium) from Allergan, Inc., approving changes to the product labeling und…
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FDA approval · 2009-06-08FDA Approved: CALCITONIN SALMON — Original Application (Endo USA, Inc.)
FDA approved Endo USA, Inc.'s Original Application for Calcitonin Salmon (generic), confirming a generic product for the drug. The approval …
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FDA approval · 2009-05-13FDA Approved: PAMIDRONATE DISODIUM — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for pamidronate disodium by Mylan Institutional LLC under an ANDA.
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FDA approval · 2008-11-17FDA Approved: CALCITONIN SALMON — Original Application (Apotex Corp.)
FDA approved Apotex Corp.'s original ANDA for Calcitonin Salmon, authorizing a generic version of the drug for its approved uses.
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FDA approval · 2008-10-08FDA Approved: FOSAMAX — Supplemental Application (Organon LLC)
The FDA approved a supplemental application for FOSAMAX (alendronate sodium) submitted by Organon LLC.
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FDA approval · 2008-08-04FDA Approved: ALENDRONATE SODIUM — Original Application (EXELAN PHARMACEUTICALS INC.)
FDA approved the original application for alendronate sodium (Exelan Pharmaceuticals Inc.), making this generic osteoporosis therapy availab…
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FDA approval · 2008-08-04FDA Approved: ALENDRONATE SODIUM — Original Application (Aurobindo Pharma Limited)
FDA approves the original application for alendronate sodium from Aurobindo Pharma Limited as a generic therapy.
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FDA approval · 2008-04-22FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for Actonel (risedronate sodium) submitted by Allergan, Inc., resulting in an approved update to the…
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FDA approval · 2008-02-06FDA Approved: ALENDRONATE SODIUM — Original Application (Amneal Pharmaceuticals of New York LLC)
FDA approved the original ANDA for Alendronate Sodium (generic) from Amneal Pharmaceuticals of New York LLC, expanding access for treatment …
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FDA approval · 2007-10-05FDA Approved: RISEDRONATE SODIUM — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approves Teva's risendronate sodium generic from an Original Application (ANDA 077132), enabling marketing of a risendronate sodium tabl…
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FDA approval · 2007-04-16FDA Approved: RECLAST — Original Application (Sandoz Inc)
FDA approves Sandoz's RECLAST (zoledronic acid) original application for osteoporosis-related indications, including postmenopausal osteopor…
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FDA approval · 2006-12-28FDA Approved: FOSAMAX — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Fosamax (alendronate sodium) submitted by Organon LLC.